Lawyers and generics

A reputed law firm opines in the context of Health Ministry’s letterNew Delhi: The letter dated 18.4.2017 sent out by the Government of India, Ministry of Health & Family Welfare to the various Secretaries in the States/UT’s enclosing a copy of the amended MCI regulation which mandates that “every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs” has caused confusion amongst doctors.

The Indian Medical Association has, on behalf of doctors, written to the Medical Council of India in this regard seeking clarification regarding certain statements in the press that doctors were banned from recommending branded drugs.

One of India’s leading law firms with extensive experience in Pharma regulatory matters and having represented clients before various High Courts and the Supreme Court has definitely and categorically opined that:

1. The generic name has to be mentioned whilst prescribing a drug but there is no prohibition on recommending a brand as well.

2. The amended regulation does not state that “only” generic name should be in the prescription.

3. Doctors have always had a good medical reason, in the best interests of the patient, to recommend specific brands. The recommendation of the brand has the assurance of quality, appropriate combination of ingredients and the ability for patients to familiarize themselves with a particular brand and is packaging for its continuous use as prescribed. Changing brands during a course of treatment could lead to non-compliance by the patient. Recommending the brand would comply with the aspect of “rational prescription and use of drugs” which continues to be the overriding rule in prescriptions.

4. There are no “generic products” in the Indian market. All drugs carry a trade name/mark and are “branded generic products”. Any prescription giving the generic (i.e. the chemical) name of the product without mentioning the brand name as well will only confuse a patient and the chemist. Given the lack of pharmacy expertise in the chemist shops and the poor knowledge of patients, failure to mention the brand could lead to fatal results for the patients.

5. In fact, the Ministry of Health and Family Welfare in a recent notification proposed amendments to the Drugs and Cosmetics Rules (Rule 96) to increase the font of the “proper name of the drug” at least two font size larger than the brand name or trade name but did not say that the brand name should not be there on the product pack which only shows that the brand name is equally important only the proper (generic) name should be bigger in size.

Doctors have been advised to continue to comply with the current practice of mentioning the generic (i.e. chemical) name of the drug prescribed along with a recommended brand in the interests of patients.